Phase
Condition
N/ATreatment
AZD5148
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent.
Participants with a qualifying C. difficile infection episode at the time of providing informed consent defined by:
Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformedstool sample collected during this episode, and
Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned durationof at least 10 and at most 25 days at time of IMP administration.
Note: Diarrhea is not required to be present on the day of investigational medicinal product (IMP) administration.
Body weight ≥ 40 kg
Exclusion
Exclusion Criteria:
History of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease, microscopic colitis).
Participant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)
Planned surgery for C. difficile infection within 24 hours of enrollment
Current toxic megacolon and/or small bowel ileus
Any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).
Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)
Due to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode
Treatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, or planned administration during the 180 days after IMP administration
Treatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.
Study Design
Study Description
Connect with a study center
Research Site
Camperdown, 2050
AustraliaActive - Recruiting
Research Site
Camperdown 2172563, 2050
AustraliaSite Not Available
Research Site
Clayton, 3168
AustraliaActive - Recruiting
Research Site
Clayton 2171400, 3168
AustraliaSite Not Available
Research Site
Herston, 4029
AustraliaActive - Recruiting
Research Site
Herston 6931014, 4029
AustraliaSite Not Available
Research Site
Melbourne, 3000
AustraliaActive - Recruiting
Research Site
Melbourne 2158177, 3000
AustraliaSite Not Available
Research Site
South Brisbane, 4101
AustraliaActive - Recruiting
Research Site
South Brisbane 2207259, 4101
AustraliaSite Not Available
Research Site
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Research Site
Edmonton 5946768, Alberta 5883102 T6G 2X8
CanadaSite Not Available
Research Site
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Research Site
Victoria, British Columbia V8T 5G4
CanadaSite Not Available
Research Site
Vancouver 6173331, British Columbia 5909050 V5Z 1M9
CanadaSite Not Available
Research Site
Victoria 6174041, British Columbia 5909050 V8T 5G4
CanadaSite Not Available
Research Site
Halifax, Nova Scotia B3K 6R8
CanadaSite Not Available
Research Site
Halifax 6324729, Nova Scotia 6091530 B3K 6R8
CanadaSite Not Available
Research Site
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
Research Site
London, Ontario N6A 5A5
CanadaSite Not Available
Research Site
Hamilton 5969782, Ontario 6093943 L8N 4A6
CanadaSite Not Available
Research Site
London 6058560, Ontario 6093943 N6C 2R5
CanadaSite Not Available
Research Site
Montreal, Quebec H4A 3S5
CanadaActive - Recruiting
Research Site
Québec, Quebec G1V 4T3
CanadaActive - Recruiting
Research Site
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Research Site
Montreal 6077243, Quebec 6115047 H4A 3S5
CanadaSite Not Available
Research Site
Québec 6325494, Quebec 6115047 G1V 4T3
CanadaSite Not Available
Research Site
Sherbrooke 6146143, Quebec 6115047 J1H 5N4
CanadaSite Not Available
Research Site
Aalborg, DK9000
DenmarkSite Not Available
Research Site
Aalborg 2624886, DK9000
DenmarkSite Not Available
Research Site
Aarhus N, 8200
DenmarkActive - Recruiting
Research Site
Aarhus N 11746890, 8200
DenmarkSite Not Available
Research Site
Hvidovre, 2650
DenmarkActive - Recruiting
Research Site
Hvidovre 2619528, 2650
DenmarkSite Not Available
Research Site
København Ø, 2100
DenmarkActive - Recruiting
Research Site
København Ø 11746747, 2100
DenmarkSite Not Available
Research Site
Odense C, 5000
DenmarkActive - Recruiting
Research Site
Odense C 11746507, 5000
DenmarkSite Not Available
Research Site
Lyon, 69317
FranceActive - Recruiting
Research Site
Lyon 2996944, 69317
FranceSite Not Available
Research Site
Montpellier, 34295
FranceSite Not Available
Research Site
Montpellier 2992166, 34295
FranceSite Not Available
Research Site
Nantes, 44093
FranceActive - Recruiting
Research Site
Nantes 2990969, 44093
FranceSite Not Available
Research Site
Nîmes, 30029
FranceActive - Recruiting
Research Site
Nîmes 2990363, 30029
FranceSite Not Available
Research Site
Paris, 75475
FranceActive - Recruiting
Research Site
Paris 2988507, 75014
FranceSite Not Available
Research Site
Tours, 37044
FranceActive - Recruiting
Research Site
Tours 2972191, 37044
FranceSite Not Available
Research Site
Augsburg, 86156
GermanySite Not Available
Research Site
Augsburg 2954172, 86156
GermanySite Not Available
Research Site
Berlin, 13353
GermanyActive - Recruiting
Research Site
Berlin 2950159, 13353
GermanySite Not Available
Research Site
Cologne, 50937
GermanyActive - Recruiting
Research Site
Cologne 2886242, 50937
GermanySite Not Available
Research Site
Frankfurt, 60590
GermanyActive - Recruiting
Research Site
Frankfurt 2925536, 60590
GermanySite Not Available
Research Site
Hamburg, 20246
GermanyActive - Recruiting
Research Site
Hamburg 2911298, 20246
GermanySite Not Available
Research Site
Jena, 07747
GermanySite Not Available
Research Site
Jena 2895044, 07747
GermanySite Not Available
Research Site
Leipzig, 04103
GermanyActive - Recruiting
Research Site
Leipzig 2879139, 04103
GermanySite Not Available
Research Site
München, 81675
GermanyActive - Recruiting
Research Site
München 2867711, 81675
GermanySite Not Available
Research Site
Athens, 11527
GreeceSite Not Available
Research Site
Athens 264371, 12462
GreeceSite Not Available
Research Site
Heraklion, 71500
GreeceSite Not Available
Research Site
Heraklion 261745, 71500
GreeceSite Not Available
Research Site
Ioannina, 45500
GreeceSite Not Available
Research Site
Ioannina 261779, 45500
GreeceSite Not Available
Research Site
Thessaloniki, 57010
GreeceActive - Recruiting
Research Site
Thessaloniki 734077, 57010
GreeceSite Not Available
Research Site
Budapest, 1082
HungaryActive - Recruiting
Research Site
Budapest 3054643, 1082
HungarySite Not Available
Research Site
Debrecen, 4031
HungaryActive - Recruiting
Research Site
Debrecen 721472, 4031
HungarySite Not Available
Research Site
Eger, 3300
HungaryActive - Recruiting
Research Site
Eger 721239, 3300
HungarySite Not Available
Research Site
Kistarcsa, 2143
HungaryActive - Recruiting
Research Site
Kistarcsa 3050290, 2143
HungarySite Not Available
Research Site
Pécs, 7624
HungaryActive - Recruiting
Research Site
Pécs 3046526, 7624
HungarySite Not Available
Research Site
Modena, 41124
ItalySite Not Available
Research Site
Modena 3173331, 41124
ItalySite Not Available
Research Site
Naples, 80131
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Napoli 9031661, 80131
ItalySite Not Available
Research Site
Palermo, 90127
ItalyActive - Recruiting
Research Site
Palermo 2523920, 90127
ItalySite Not Available
Research Site
Pisa, 56124
ItalyActive - Recruiting
Research Site
Pisa 3170647, 56124
ItalySite Not Available
Research Site
Roma, 00161
ItalySite Not Available
Research Site
Roma 8957247, 00161
ItalySite Not Available
Research Site
Varese, 21100
ItalySite Not Available
Research Site
Varese 3164699, 21100
ItalySite Not Available
Research Site
Kochi, 780-8522
JapanActive - Recruiting
Research Site
Kochi 1859146, 780-8522
JapanSite Not Available
Research Site
Kumamoto, 861-8520
JapanActive - Recruiting
Research Site
Kumamoto 1858421, 861-8520
JapanSite Not Available
Research Site
Meguro-ku, 153-0051
JapanActive - Recruiting
Research Site
Nagasaki, 852-8501
JapanActive - Recruiting
Research Site
Nagasaki 1856177, 852-8501
JapanSite Not Available
Research Site
Shimonoseki-shi, 750-8520
JapanActive - Recruiting
Research Site
Yaizu-shi, 425-8505
JapanActive - Recruiting
Research Site
Lublin, 20-081
PolandSite Not Available
Research Site
Lublin 765876, 20-081
PolandSite Not Available
Research Site
Warsaw, 04-141
PolandSite Not Available
Research Site
Warsaw 756135, 04-141
PolandSite Not Available
Research Site
Alicante, 03010
SpainActive - Recruiting
Research Site
Alicante 2521978, 03010
SpainSite Not Available
Research Site
Badalona, 08916
SpainActive - Recruiting
Research Site
Badalona 3129028, 08916
SpainSite Not Available
Research Site
Madrid, 28046
SpainActive - Recruiting
Research Site
Madrid 3117735, 28034
SpainSite Not Available
Research Site
Majadahonda, 28220
SpainActive - Recruiting
Research Site
Majadahonda 3117667, 28220
SpainSite Not Available
Research Site
Seville, 41009
SpainActive - Recruiting
Research Site
Seville 2510911, 41009
SpainSite Not Available
Research Site
Helsingborg, 25187
SwedenSite Not Available
Research Site
Helsingborg 2706767, 25187
SwedenSite Not Available
Research Site
Lund, 22185
SwedenSite Not Available
Research Site
Lund 2693678, 22185
SwedenSite Not Available
Research Site
Malmo, 20502
SwedenSite Not Available
Research Site
Malmo 2692969, 20502
SwedenSite Not Available
Research Site
Malmö, 20502
SwedenSite Not Available
Research Site
Västerås, 72189
SwedenActive - Recruiting
Research Site
Västerås 2664454, 72189
SwedenSite Not Available
Research Site
Birmingham, B15 2TH
United KingdomActive - Recruiting
Research Site
Birmingham 2655603, B15 2TH
United KingdomSite Not Available
Research Site
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Research Site
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
Research Site
Phoenix, Arizona 85032
United StatesSite Not Available
Research Site
Phoenix 5308655, Arizona 5551752 85032
United StatesSite Not Available
Research Site
Chula Vista, California 91911
United StatesSite Not Available
Research Site
Sacramento, California 95817
United StatesSite Not Available
Research Site
Torrance, California 90502
United StatesActive - Recruiting
Research Site
Chula Vista 5336899, California 5332921 91911
United StatesSite Not Available
Research Site
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
Research Site
Torrance 5403022, California 5332921 90502
United StatesSite Not Available
Research Site
Hamden, Connecticut 06518
United StatesActive - Recruiting
Research Site
Hamden 4835654, Connecticut 4831725 06518
United StatesSite Not Available
Research Site
Gainesville, Florida 32605
United StatesActive - Recruiting
Research Site
Hialeah, Florida 33016
United StatesSite Not Available
Research Site
Homestead, Florida 33033
United StatesActive - Recruiting
Research Site
Jacksonville, Florida 32256
United StatesActive - Recruiting
Research Site
Miami Lakes, Florida 33014
United StatesSite Not Available
Research Site
Miramar, Florida 33027
United StatesActive - Recruiting
Research Site
Port Orange, Florida 32127
United StatesSite Not Available
Research Site
Tamarac, Florida 33321
United StatesActive - Recruiting
Research Site
Tampa, Florida 33607
United StatesSite Not Available
Research Site
Gainesville 4156404, Florida 4155751 32605
United StatesSite Not Available
Research Site
Homestead 4159050, Florida 4155751 33033
United StatesSite Not Available
Research Site
Jacksonville 4160021, Florida 4155751 32256
United StatesSite Not Available
Research Site
Miami Lakes 4164186, Florida 4155751 33014
United StatesSite Not Available
Research Site
Miramar 4164601, Florida 4155751 33027
United StatesSite Not Available
Research Site
Port Orange 4169156, Florida 4155751 32127
United StatesSite Not Available
Research Site
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33607
United StatesSite Not Available
Research Site
Athens, Georgia 30606
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Athens 4180386, Georgia 4197000 30606
United StatesSite Not Available
Research Site
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Research Site
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Research Site
Idaho Falls 5596475, Idaho 5596512 83404
United StatesSite Not Available
Research Site
Burr Ridge, Illinois 60527
United StatesActive - Recruiting
Research Site
Burr Ridge 4886090, Illinois 4896861 60527
United StatesSite Not Available
Research Site
Lexington, Kentucky 40509
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesSite Not Available
Research Site
Lexington 4297983, Kentucky 6254925 40509
United StatesSite Not Available
Research Site
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Research Site
New Orleans, Louisiana 70121
United StatesSite Not Available
Research Site
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Research Site
Glen Burnie, Maryland 21061
United StatesActive - Recruiting
Research Site
Potomac, Maryland 20854
United StatesActive - Recruiting
Research Site
Glen Burnie 4356188, Maryland 4361885 21061
United StatesSite Not Available
Research Site
Potomac 4366001, Maryland 4361885 20854
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesSite Not Available
Research Site
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Research Site
Detroit, Michigan 48202
United StatesActive - Recruiting
Research Site
Royal Oak, Michigan 48073
United StatesSite Not Available
Research Site
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Research Site
Royal Oak 5007804, Michigan 5001836 48073
United StatesSite Not Available
Research Site
Columbia, Missouri 65212
United StatesSite Not Available
Research Site
St Louis, Missouri 63130
United StatesSite Not Available
Research Site
Columbia 4381982, Missouri 4398678 65212
United StatesSite Not Available
Research Site
St Louis 4407066, Missouri 4398678 63130
United StatesSite Not Available
Research Site
Union City, New Jersey 07087
United StatesSite Not Available
Research Site
Hartsdale, New York 10530
United StatesSite Not Available
Research Site
Inwood, New York 11096
United StatesSite Not Available
Research Site
The Bronx, New York 10451
United StatesActive - Recruiting
Research Site
Hartsdale 5120141, New York 5128638 10530
United StatesSite Not Available
Research Site
Inwood 5122280, New York 5128638 11096
United StatesSite Not Available
Research Site
The Bronx 5110266, New York 5128638 10451
United StatesSite Not Available
Research Site
Salisbury, North Carolina 28144
United StatesActive - Recruiting
Research Site
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Research Site
Salisbury 4489985, North Carolina 4482348 28144
United StatesSite Not Available
Research Site
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15237
United StatesSite Not Available
Research Site
Johnson City, Tennessee 37614
United StatesSite Not Available
Research Site
Johnson City 4633419, Tennessee 4662168 37614
United StatesSite Not Available
Research Site
Charlottesville, Virginia 22903
United StatesSite Not Available
Research Site
Lynchburg, Virginia 24501
United StatesActive - Recruiting
Research Site
Roanoke, Virginia 24014
United StatesActive - Recruiting
Research Site
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Research Site
Lynchburg 4771075, Virginia 6254928 24501
United StatesSite Not Available
Research Site
Roanoke 4782167, Virginia 6254928 24014
United StatesSite Not Available
Research Site
Seattle, Washington 98109
United StatesSite Not Available
Research Site
Seattle 5809844, Washington 5815135 98109
United StatesSite Not Available
Research Site
Madison, Wisconsin 53705
United StatesSite Not Available
Research Site
Madison 5261457, Wisconsin 5279468 53705
United StatesSite Not Available

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